Dupuytren's Contracture
Conditions
Keywords
Dupuytren's, treatment, injection, recovery, health care resources
Brief summary
This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).
Interventions
DRUGXiapex
Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Presenting with a Dupuytren's contracture of at least 20 degrees caused by a palpable cord in at least one finger other than the thumb. * Positive table top test defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Exclusion criteria
* Received a treatment on the selected joint, within 90 days of enrollment in the study, for Dupuytren's contracture including needle aponeurotomy or any surgical procedure * On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150 mg daily) within 7 days before the first injection * Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Passive Extension Deficit (TPED) at Day 180 After Last Injection | Day 180 after last injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Baseline for First Injection | Baseline for first injection | TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Baseline for Second Injection | Baseline for second injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Baseline for Third Injection | Baseline for third injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection | Baseline for fourth injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 1 After First Injection | Day 1 after first injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 7 After First Injection | Day 7 after first injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 30 After First Injection | Day 30 after first injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 1 After Second Injection | Day 1 after second injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 7 After Second Injection | Day 7 after second injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 30 After Second Injection | Day 30 after second injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 1 After Third Injection | Day 1 after third injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 7 After Third Injection | Day 7 after third injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 30 After Third Injection | Day 30 after third injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection | Day 1 after fourth injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection | Day 7 after fourth injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection | Day 30 after fourth injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Total Passive Extension Deficit (TPED) at Day 90 After Last Injection | Day 90 after last injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection | Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many times since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed. |
| Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection | Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many days since their last visit they 1) were hospitalized, 2) were in nursing home, 3) required aids/devices to assist in their daily functioning. |
| Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection | PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint. |
| Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection | TPED was defined as sum of PED in MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was TPED value taken closest and prior to administration of that particular injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). Change in TPED was reported at Day 1, 7 and 30 after each injection for fingers that received 1 through 4 injections and at Day 90, 180 after last injection, where last injection was a maximum up to fourth injection for a finger. Results are not reported for fifth injection as no finger received 5 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection | PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. Change in PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint. |
| Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection | Finger goniometry was used to measure the angles of extension and flexion of MP and PIP joints. ROM was measured as the difference between the angle of flexion and the angle of extension of the joint. For each injection, baseline value was the ROM value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the ROM value taken closest and prior to administration of first injection in that joint. ROM was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint. |
| Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection | Participant global assessment questionnaire assessed severity of the contracture at baseline, post-injection and treatment satisfaction (TS), improvement from baseline in the treated contracture at post-injection only. Participants rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Participants rated their improvement in disease severity relative to baseline on a 11-point scale ranging from 0 percent (%) = no improvement to 100% = total recovery, with 10 % increment between each point. Results are reported for number of participants in each category for disease severity, TS and improvement. |
| Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection | Physician global assessment questionnaire assessed severity of the contracture at baseline, post-injection and TS, improvement from baseline in the treated contracture at post-injection only. Physician's rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Physicians rated participant's improvement in disease severity relative to baseline as very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse. |
| Number of Participants With Type of Concomitant Pain Medication Used | Screening up to Day 180 after last injection | Number of participants who took different types of analgesic medications, including acetylsalicylic acid, other analgesics (any other analgesic besides those mentioned, as approved by the investigator), aporex, codis, dihydrocodeine, fentanyl, galenic/paracetamol/codeine/, hot coldrex, metamizole, morphine, oxycodone, panadeine CO (combination of paracetamol and codeine phosphate), paracetamol, paramol-118, pregabalin, solpadeine, tramadol, ultracet, to manage pain symptoms were reported. A single participant may be represented in more than 1 category. |
| Number of Days of Concomitant Pain Medication Usage | Screening up to Day 180 after last injection | Amount of concomitant pain medication was assessed as the number of days participants used pain medication during the study. |
| Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30 | Dupuytren's daily diary questionnaire assessed number of days during a cycle when 1) participant was absent or sick due to treatment, 2) the work hours were reduced, 3) the job duties were modified, 4) participant was unable to participate in hobbies and 5) participant wore a splint (for participants who were fitted for a splint). |
| Time to Recovery | Up to Day 30 after first, second and third injection | Time to recovery of normal activities was defined as median number of days between the initial injection date and the date on which participant recovered to normal activities, assessed after first, second and third injection for joints that received 1 through 3 injections. If a participant did not achieve recovery to normal activities, the participant's time to recovery was defined as the median number of days between the initial injection date and the date of the participant's the last daily diary recording within the cycle. |
| Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection | URAM:9-item questionnaire used to assess daily hand functionality.Participants rated their ability to perform following hand functionalities on 0 to 5 scale(0=without difficulty,5=impossible):1)washing themselves with flannel, keeping hand flat,2)washing face,3)holding bottle in one hand,4)shaking someone's hand,5)stroking/caressing someone,6)clapping,7)spreading out fingers, 8)leaning on hand,9)picking up small objects with thumb and index finger.URAM total score=sum of 9 items.Total score range=0 to 45,where higher score= higher difficulty in daily hand functionality.For each cycle, baseline value=pre-injection value reported at that cycle. For follow-up on Day 90,180 after last injection, baseline value (follow-up baseline)=pre-injection value reported at cycle 1. If response was provided to less than or equal to 4 items,URAM total score was considered missing. If response was provided to \>=5 items, then average score of answered questions was imputed response to missing questions. |
| Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection | Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered whether or not since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed, 7) were admitted in nursing home, 8) required aids/devices to assist in their daily functioning. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Screening up to Day 180 after last injection | Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate, radial pulse and body temperature. |
| Number of Participants With Anti-Drug Antibody (ADA) | Screening, Follow-up Day 180 after last injection | Human serum ADA samples were analyzed for the presence or absence of anti-clostridial type I collagenase (AUX-I) and anti-clostridial type II collagenase (AUX-II) antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). |
| Number of Participants With Laboratory Abnormalities | Screening up to Day 180 after last injection | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity \[pH\], glucose, protein, blood, ketones, microscopy\[if urine tested positive for blood or protein\]). |
Countries
Denmark, France, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xiapex A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle. | 254 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Xiapex |
|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 7.37 |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 223 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 212 / 254 |
| serious Total, serious adverse events | 12 / 254 |
Outcome results
Primary
Total Passive Extension Deficit (TPED) at Baseline for First Injection
TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Baseline for first injection
Population: Full analysis set(FAS):participants who received at least (\>=)1 injection of Xiapex,had \>=1 post-injection efficacy assessment(goniometric/participant-reported). 'N'(number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Baseline for First Injection | 55.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Baseline for fourth injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection | 20.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Baseline for Second Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Baseline for second injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Baseline for Second Injection | 45.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Baseline for Third Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Baseline for third injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Baseline for Third Injection | 40.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 180 After Last Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 180 after last injection
Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 180 After Last Injection | 14.5 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 1 After First Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 1 after first injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 1 After First Injection | 20.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 1 after fourth injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection | 0.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 1 After Second Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 1 after second injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 1 After Second Injection | 29.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 1 After Third Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 1 after third injection
Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 1 After Third Injection | 15.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 30 After First Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 30 after first injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 30 After First Injection | 10.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 30 after fourth injection
Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection | 10.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 30 After Second Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 30 after second injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 30 After Second Injection | 20.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 30 After Third Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 30 after third injection
Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 30 After Third Injection | 30.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 7 After First Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 7 after first injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 7 After First Injection | 10.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 7 after fourth injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection | 0.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 7 After Second Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 7 after second injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 7 After Second Injection | 20.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 7 After Third Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 7 after third injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 7 After Third Injection | 22.0 degrees |
Primary
Total Passive Extension Deficit (TPED) at Day 90 After Last Injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Day 90 after last injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Total Passive Extension Deficit (TPED) at Day 90 After Last Injection | 10.0 degrees |
Secondary
Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection
PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. Change in PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.
Time frame: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 1 after first injection: MP(n=207) | -30.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 7 after first injection: MP(n=209) | -30.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 30 after first injection: MP(n=209) | -35.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 1 after second injection: MP(n=33) | -20.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 7 after second injection: MP(n=33) | -20.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 30 after second injection: MP(n=32) | -20.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 1 after third injection: MP(n=9) | -10.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 7 after third injection: MP(n=9) | -10.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 30 after third injection: MP(n=9) | -10.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Follow-up Day 90: MP(n=201) | -35.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Follow-up Day 180: MP(n=207) | -35.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 1 after first injection: PIP(n=98) | -25.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 7 after first injection: PIP(n=97) | -30.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 30 after first injection: PIP(n=98) | -30.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 1 after second injection: PIP(n=15) | -10.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 7 after second injection: PIP(n=18) | -12.5 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 30 after second injection: PIP(n=18) | -14.5 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 1 after third injection: PIP(n=6) | -20.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 7 after third injection: PIP(n=6) | -16.5 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Day 30 after third injection: PIP(n=6) | -15.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Follow-up Day 90: PIP(n=93) | -20.0 degrees |
| Xiapex | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Change at Follow-up Day 180: PIP(n=93) | -20.0 degrees |
Secondary
Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection
TPED was defined as sum of PED in MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was TPED value taken closest and prior to administration of that particular injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). Change in TPED was reported at Day 1, 7 and 30 after each injection for fingers that received 1 through 4 injections and at Day 90, 180 after last injection, where last injection was a maximum up to fourth injection for a finger. Results are not reported for fifth injection as no finger received 5 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Time frame: Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection
Population: FAS population. 'N' (number of participants analyzed) includes total number of participants in FAS,however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. Here, 'n' signifies number of fingers/joints evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 1 after first injection (n=256) | -31.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 7 after first injection (n=256) | -40.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 30 after first injection (n=257) | -40.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 1 after second injection (n=64) | -20.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 7 after second injection (n=65) | -20.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 30 after second injection (n=64) | -20.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 1 after third injection (n=19) | -15.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 7 after third injection (n=21) | -10.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 30 after third injection (n=21) | -10.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 1 after fourth injection (n=1) | -20.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 7 after fourth injection (n=1) | -20.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Day 30 after fourth injection (n=1) | -10.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Follow-up Day 90 (n=244) | -40.0 degrees |
| Xiapex | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Change at Follow-up Day 180 (n=250) | -35.0 degrees |
Secondary
Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score
URAM:9-item questionnaire used to assess daily hand functionality.Participants rated their ability to perform following hand functionalities on 0 to 5 scale(0=without difficulty,5=impossible):1)washing themselves with flannel, keeping hand flat,2)washing face,3)holding bottle in one hand,4)shaking someone's hand,5)stroking/caressing someone,6)clapping,7)spreading out fingers, 8)leaning on hand,9)picking up small objects with thumb and index finger.URAM total score=sum of 9 items.Total score range=0 to 45,where higher score= higher difficulty in daily hand functionality.For each cycle, baseline value=pre-injection value reported at that cycle. For follow-up on Day 90,180 after last injection, baseline value (follow-up baseline)=pre-injection value reported at cycle 1. If response was provided to less than or equal to 4 items,URAM total score was considered missing. If response was provided to \>=5 items, then average score of answered questions was imputed response to missing questions.
Time frame: Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection
Population: FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Baseline for cycle 1 (n=85) | 13.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | C1D30 (n=89) | 3.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Baseline for cycle 2 (n=47) | 7.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | C2D30 (n=51) | 4.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Baseline for cycle 3 (n=31) | 8.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | C3D30 (n=31) | 3.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Baseline for cycle 4 (n=15) | 6.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | C4D30 (n=15) | 5.6 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Baseline for cycle 5 (n=9) | 9.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | C5D30 (n=9) | 2.3 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Baseline for Follow-up Day 90 (n=82) | 13.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Follow-up Day 90 (n=108) | 1.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Baseline for Follow-up Day 180 (n=83) | 13.0 units on a scale |
| Xiapex | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Follow-up Day 180 (n=126) | 0.5 units on a scale |
Secondary
Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many days since their last visit they 1) were hospitalized, 2) were in nursing home, 3) required aids/devices to assist in their daily functioning.
Time frame: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Population: FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of days was not analyzed for participants who responded that they did not perform the event.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Required aids/devices (n=1) | 20.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Required aids/devices (n=1) | 8.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Hospitalization (n=1) | 2.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Required aids/devices (n=1) | 2.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Hospitalization (n=2) | 8.5 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Required aids/devices (n=1) | 8.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Hospitalization (n=1) | 3.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Required aids/devices(n=1) | 6.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Required aids/devices (n=1) | 5.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 4: Required aids/devices (n=1) | 5.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up: Day 90: Hospitalization (n=4) | 9.5 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up: Day 90: In nursing home (n=1) | 21.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up: Day 90: Required aids/devices(n=1) | 16.0 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up: Day 180: Hospitalization (n=6) | 2.5 days |
| Xiapex | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up: Day 180: Required aids/devices (n=1) | 2.0 days |
Secondary
Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire
Dupuytren's daily diary questionnaire assessed number of days during a cycle when 1) participant was absent or sick due to treatment, 2) the work hours were reduced, 3) the job duties were modified, 4) participant was unable to participate in hobbies and 5) participant wore a splint (for participants who were fitted for a splint).
Time frame: C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30
Population: FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C4D1 to C4D30: Not participated in hobbies (n=19) | 2.0 days | Full Range 3.75 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C1D1 to C1D30: Absent or on sick leave (n=230) | 3.0 days | Full Range 3.8 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C1D1 to C1D30: Reduced work hours (n=230) | 2.0 days | Full Range 3.43 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C1D1 to C1D30: Modified job duties (n=230) | 2.0 days | Full Range 3.62 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C1D1 to C1D30: Not participated in hobbies (n=230) | 5.0 days | Full Range 4.61 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C1D1 to C1D30: Fitted with splint (n=211) | 12.0 days | Full Range 3.91 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C2D1 to C2D30: Absent or on sick leave (n=103) | 3.0 days | Full Range 3.33 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C2D1 to C2D30: Reduced work hours (n=103) | 2.0 days | Full Range 3.11 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C2D1 to C2D30: Modified job duties (n=103) | 2.0 days | Full Range 3.41 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C2D1 to C2D30: Not participated in hobbies (n=103) | 5.0 days | Full Range 4.61 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C2D1 to C2D30: Fitted with splint (n=96) | 11.0 days | Full Range 4.28 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C3D1 to C3D30: Absent or on sick leave (n=51) | 2.0 days | Full Range 4.53 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C3D1 to C3D30: Reduced work hours (n=51) | 3.0 days | Full Range 4.53 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C3D1 to C3D30: Modified job duties (n=51) | 3.0 days | Full Range 4.83 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C3D1 to C3D30: Not participated in hobbies (n=51) | 3.0 days | Full Range 5.05 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C3D1 to C3D30: Fitted with splint (n=44) | 10.0 days | Full Range 4.2 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C4D1 to C4D30: Absent or on sick leave (n=19) | 2.5 days | Full Range 3.61 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C4D1 to C4D30: Reduced work hours (n=19) | 2.0 days | Full Range 2.51 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C4D1 to C4D30: Modified job duties (n=19) | 2.0 days | Full Range 2.25 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C4D1 to C4D30: Fitted with splint (n=15) | 10.5 days | Full Range 4.11 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C5D1 to C5D30: Absent or on sick leave (n=6) | 8.5 days | Full Range 4.95 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C5D1 to C5D30: Reduced work hours (n=6) | 8.5 days | Full Range 10.61 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C5D1 to C5D30: Modified job duties (n=6) | 10.5 days | Full Range 7.78 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C5D1 to C5D30: Not participated in hobbies (n=6) | 13.0 days | Full Range 6.22 |
| Xiapex | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C5D1 to C5D30: Fitted with splint (n=5) | 11.0 days | Full Range 5.94 |
Secondary
Number of Days of Concomitant Pain Medication Usage
Amount of concomitant pain medication was assessed as the number of days participants used pain medication during the study.
Time frame: Screening up to Day 180 after last injection
Population: Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Xiapex | Number of Days of Concomitant Pain Medication Usage | 2.0 days |
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many times since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed.
Time frame: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Population: FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of events was not analyzed for participants who responded that they did not perform the event.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Diagnostic test (n=2) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Seen any doctor (n=14) | 2.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Received any therapy (n=7) | 2.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Treated in emergency room (n=2) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Outpatient surgery (n=3) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Hospitalization (n=2) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Diagnostic test (n=4) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: Seen any doctor (n=4) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: Received any therapy (n=1) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: Outpatient surgery (n=1) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: Diagnostic test (n=2) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Seen any doctor (n=4) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Received any therapy (n=3) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Outpatient surgery (n=3) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Seen any doctor (n=5) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Received any therapy (n=3) | 4.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Outpatient surgery (n=1) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Hospitalization (n=1) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Diagnostic test (n=2) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 3: Seen any doctor (n=1) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 3: Diagnostic test (n=2) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D7: Seen any doctor (n=1) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D7: Outpatient surgery (n=1) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Seen any doctor (n=2) | 2.5 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Received any therapy (n=1) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Outpatient surgery (n=1) | 3.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 4: Seen any doctor (n=1) | 2.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D7: Received any therapy (n=2) | 3.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D30: Seen any doctor (n=1) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D30: Received any therapy (n=1) | 6.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Seen any doctor (n=10) | 1.5 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Received any therapy (n=8) | 2.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Treated in emergency room (n=8) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Outpatient surgery (n=11) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Hospitalization (n=4) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Diagnostic test (n=4) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Seen any doctor (n=4) | 1.5 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Received any therapy (n=3) | 3.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Treated in emergency room (n=8) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Outpatient surgery (n=9) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Hospitalization (n=6) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Diagnostic test (n=1) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Seen any doctor (n=10) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Treated in emergency room (n=1) | 2.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Outpatient surgery (n=2) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Diagnostic test (n=2) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Seen any doctor (n=21) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Received any therapy (n=12) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Treated in emergency room (n=4) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Outpatient surgery (n=8) | 1.0 events |
| Xiapex | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Hospitalization (n=1) | 1.0 events |
Secondary
Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered whether or not since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed, 7) were admitted in nursing home, 8) required aids/devices to assist in their daily functioning.
Time frame: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Treated in emergency room (n=251) | 2 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2:Treated in emergency room(n=111) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Seen any doctor (n=254) | 10 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Received any therapy (n=254) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1:Treated in emergency room(n=254) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Outpatient surgery (n=254) | 2 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Hospitalization (n=254) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Diagnostic test (n=254) | 2 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: In nursing home (n=254) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 1: Required aids/devices (n=254) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Seen any doctor (n=252) | 21 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Received any therapy (n=252) | 12 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Treated in emergency room (n=252) | 4 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Outpatient surgery (n=252) | 9 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Hospitalization (n=252) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Diagnostic test (n=252) | 2 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: In nursing home (n=252) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D7: Required aids/devices (n=252) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Seen any doctor (n=251) | 14 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Received any therapy (n=251) | 7 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Outpatient surgery (n=251) | 3 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Hospitalization (n=251) | 2 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Diagnostic test (n=251) | 4 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: In nursing home (n=251) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C1D30: Required aids/devices (n=251) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: Seen any doctor (n=111) | 4 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: Received any therapy (n=111) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: Outpatient surgery (n=111) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: Hospitalization (n=111) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: Diagnostic test (n=111) | 2 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: In nursing home (n=111) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 2: Required aids/devices (n=111) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Seen any doctor (n=112) | 4 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Received any therapy (n=112) | 4 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Treated in emergency room (n=112) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Outpatient surgery (n=112) | 3 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Hospitalization (n=112) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Diagnostic test (n=112) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: In nursing home (n=112) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D7: Required aids/devices (n=112) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Seen any doctor (n=111) | 5 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Received any therapy (n=111) | 3 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Treated in emergency room (n=111) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Outpatient surgery (n=111) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Hospitalization (n=111) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Diagnostic test (n=111) | 2 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: In nursing home (n=111) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C2D30: Required aids/devices (n=111) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 3: Seen any doctor (n=51) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 3: Received any therapy (n=51) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 3:Treated in emergency room(n=51) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 3: Outpatient surgery (n=51) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 3: Hospitalization (n=51) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 3: Diagnostic test (n=51) | 2 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 3: In nursing home (n=51) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 3: Required aids/devices (n=51) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D7: Seen any doctor (n=54) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D7: Received any therapy (n=54) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D7: Treated in emergency room (n=54) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D7: Outpatient surgery (n=54) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D7: Hospitalization (n=54) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D7: Diagnostic test (n=54) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D7: In nursing home (n=54) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D7: Required aids/devices (n=54) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Seen any doctor (n=54) | 2 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Received any therapy (n=54) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Treated in emergency room (n=54) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Outpatient surgery (n=54) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Hospitalization (n=54) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Diagnostic test (n=54) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: In nursing home (n=54) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C3D30: Required aids/devices (n=54) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 4: Seen any doctor (n=23) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 4: Received any therapy (n=23) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 4:Treated in emergency room(n=23) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 4: Outpatient surgery (n=23) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 4: Hospitalization (n=23) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 4: Diagnostic test (n=23) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 4: In nursing home (n=23) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 4: Required aids/devices (n=23) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D7: Seen any doctor (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D7: Received any therapy (n=24) | 2 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D7: Treated in emergency room (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D7: Outpatient surgery (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D7: Hospitalization (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D7: Diagnostic test (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D7: In nursing home (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D7: Required aids/devices (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D30: Seen any doctor (n=24) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D30: Received any therapy (n=24) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D30: Treated in emergency room (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D30: Outpatient surgery (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D30: Hospitalization (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D30: Diagnostic test (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D30: In nursing home (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C4D30: Required aids/devices (n=24) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 5: Seen any doctor (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 5: Received any therapy (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 5:Treated in emergency room(n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 5: Outpatient surgery (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 5: Hospitalization (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 5: Diagnostic test (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 5: In nursing home (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline cycle 5: Required aids/devices (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D7: Seen any doctor (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D7: Received any therapy (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D7: Treated in emergency room (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D7: Outpatient surgery (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D7: Hospitalization (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D7: Diagnostic test (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D7: In nursing home (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Seen any doctor (n=247) | 10 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D7: Required aids/devices (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D30: Seen any doctor (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D30: Received any therapy (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D30: Treated in emergency room (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D30: Outpatient surgery (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D30: Hospitalization (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D30: Diagnostic test (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D30: In nursing home (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | C5D30: Required aids/devices (n=12) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Received any therapy (n=247) | 8 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90:Treated in emergency room(n=247) | 8 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Outpatient surgery (n=247) | 11 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Hospitalization (n=247) | 4 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: Diagnostic test (n=247) | 4 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90: In nursing home (n=247) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 90:Required aids/devices(n=247) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Seen any doctor (n=249) | 4 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Received any therapy (n=249) | 3 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180:Treated in emergency room(n=249) | 8 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Outpatient surgery (n=249) | 9 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Hospitalization (n=248) | 6 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Diagnostic test (n=247) | 1 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: In nursing home (n=248) | 0 participants |
| Xiapex | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Follow-up Day 180: Required aids/devices (n=248) | 3 participants |
Secondary
Number of Participants With Type of Concomitant Pain Medication Used
Number of participants who took different types of analgesic medications, including acetylsalicylic acid, other analgesics (any other analgesic besides those mentioned, as approved by the investigator), aporex, codis, dihydrocodeine, fentanyl, galenic/paracetamol/codeine/, hot coldrex, metamizole, morphine, oxycodone, panadeine CO (combination of paracetamol and codeine phosphate), paracetamol, paramol-118, pregabalin, solpadeine, tramadol, ultracet, to manage pain symptoms were reported. A single participant may be represented in more than 1 category.
Time frame: Screening up to Day 180 after last injection
Population: Safety set included all participants who received at least 1 injection of Xiapex.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Acetylsalicylic acid | 5 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Other analgesics | 2 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Aporex | 1 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Codis | 1 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Dihydrocodeine | 1 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Fentanyl | 3 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Galenic/Paracetamol/Codeine | 2 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Hot coldrex | 1 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Metamizole | 4 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Morphine | 3 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Oxycodone | 1 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Panadeine CO | 11 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Paracetamol | 96 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Paramol-118 | 1 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Pregabalin | 2 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Solpadeine | 1 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Tramadol | 7 participants |
| Xiapex | Number of Participants With Type of Concomitant Pain Medication Used | Ultracet | 2 participants |
Secondary
Participant Global Assessment of Treatment Satisfaction and Disease Severity
Participant global assessment questionnaire assessed severity of the contracture at baseline, post-injection and treatment satisfaction (TS), improvement from baseline in the treated contracture at post-injection only. Participants rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Participants rated their improvement in disease severity relative to baseline on a 11-point scale ranging from 0 percent (%) = no improvement to 100% = total recovery, with 10 % increment between each point. Results are reported for number of participants in each category for disease severity, TS and improvement.
Time frame: Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection
Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, severity: severe (n=54) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, severity: moderate (n=54) | 16 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, TS: satisfied (n=109) | 37 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, TS: neither satisfied/dissatisfied (n=109) | 6 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, TS: dissatisfied (n=109) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, TS: very dissatisfied (n=109) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 0% (n=109) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 10% (n=109) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 20% (n=109) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 30% (n=109) | 7 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 40% (n=109) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 50% (n=109) | 10 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 60% (n=109) | 9 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 70% (n=109) | 8 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 80% (n=109) | 13 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 90% (n=109) | 33 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement: 100% (n=109) | 18 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 3, severity: normal (n=54) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 3, severity: mild (n=54) | 14 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 3, severity: moderate (n=54) | 25 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 3, severity: severe (n=54) | 14 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, severity: normal (n=54) | 8 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, severity: mild (n=54) | 26 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, TS: very satisfied (n=54) | 29 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, TS: satisfied (n=54) | 18 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, TS: neither satisfied/dissatisfied (n=54) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, TS: dissatisfied (n=54) | 3 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: 0% (n=54) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: 10% (n=54) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: 20% (n=54) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: 30% (n=54) | 3 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: 40% (n=54) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: 60% (n=54) | 7 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: 70% (n=54) | 11 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: 80% (n=54) | 8 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: 90% (n=54) | 16 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: 100% (n=54) | 3 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 4, severity: mild (n=24) | 11 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 4, severity: moderate (n=24) | 9 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 4, severity: severe (n=24) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, severity: normal (n=24) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, severity: mild (n=24) | 13 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, severity: moderate (n=24) | 8 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, severity: severe (n=24) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, TS: very satisfied (n=24) | 13 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, TS: satisfied (n=24) | 9 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, TS: dissatisfied (n=24) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: 10% (n=24) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: 20% (n=24) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: 40% (n=24) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: 50% (n=24) | 3 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: 60% (n=24) | 3 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: 70% (n=24) | 3 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: 80% (n=24) | 5 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: 90% (n=24) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: 100% (n=24) | 3 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 5, severity: mild (n=12) | 7 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 5, severity: moderate (n=12) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 5, severity: severe (n=12) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, severity: normal (n= 12) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, severity: mild (n= 12) | 6 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, severity: moderate (n= 12) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, severity: severe (n= 12) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, TS: very satisfied (n= 12) | 8 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, TS: satisfied (n= 12) | 3 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, TS: neither satisfied/dissatisfied (n= 12) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, improvement: 10% (n= 12) | 1 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, improvement: 70% (n= 12) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, improvement: 80% (n= 12) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, improvement: 90% (n= 12) | 5 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, severity: normal (n=246) | 92 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, severity: mild (n=246) | 102 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, severity: moderate (n=246) | 43 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, severity: severe (n=246) | 9 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, TS: very satisfied (n=247) | 163 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, TS: satisfied (n=247) | 57 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90,TS:neither satisfied/dissatisfied(n=247) | 10 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, TS: satisfaction: dissatisfied (n=247) | 13 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, TS:very dissatisfied (n=247) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 0% (n=247) | 7 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 10% (n=247) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 20% (n=247) | 6 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 30% (n=247) | 3 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 40% (n=247) | 6 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 50% (n=247) | 13 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 60% (n=247) | 5 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 70% (n=247) | 20 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 80% (n=247) | 42 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 90% (n=247) | 78 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: 100% (n=247) | 63 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, severity: normal (n=248) | 78 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, severity: mild (n=248) | 96 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, severity: moderate (n=248) | 54 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, severity: severe (n=248) | 20 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, TS: very satisfied (n=249) | 152 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, TS: satisfied (n=249) | 64 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day180,TS:neither satisfied/dissatisfied(n=249) | 13 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180,TS: dissatisfied (n=249) | 15 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180,TS: very dissatisfied (n=249) | 5 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 0% (n=249) | 17 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 10% (n=249) | 5 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 20% (n=249) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 30% (n=249) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 40% (n=249) | 4 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 50% (n=249) | 15 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 60% (n=249) | 6 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 70% (n=249) | 21 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 80% (n=249) | 43 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 90% (n=249) | 74 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: 100% (n=249) | 58 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, severity: normal (n=254) | 2 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, severity: mild (n=254) | 40 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, severity: moderate (n=254) | 128 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, severity: severe (n=254) | 84 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, severity: normal (n=253) | 63 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, severity: mild (n=253) | 114 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, severity: moderate (n=253) | 55 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, severity: severe (n=253) | 21 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, TS: very satisfied (n=253) | 153 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, TS: satisfied (n=253) | 73 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, TS: neither satisfied/dissatisfied (n=253) | 16 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, TS: dissatisfied (n=253) | 6 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, TS: very dissatisfied (n=253) | 5 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 0% (n=252) | 10 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 10% (n=252) | 11 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 20% (n=252) | 6 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 30% (n=252) | 8 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 40% (n=252) | 6 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 50% (n=252) | 20 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 60% (n=252) | 15 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 70% (n=252) | 19 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 80% (n=252) | 52 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 90% (n=252) | 58 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: 100% (n=252) | 47 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 2, severity: mild (n=112) | 22 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 2, severity: moderate (n=112) | 62 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 2, severity: severe (n=112) | 28 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, severity: normal (n=109) | 27 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, severity: mild (n=109) | 47 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, severity: moderate (n=109) | 24 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, severity: severe (n=109) | 11 participants |
| Xiapex | Participant Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, TS: very satisfied (n=109) | 64 participants |
Secondary
Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints
PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.
Time frame: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after first injection: MP Joint (n=209) | 0.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for first injection: MP Joint (n=211) | 40.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after first injection: MP Joint (n=207) | 8.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after first injection: MP Joint (n=209) | 0.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for second injection: MP Joint (n=33) | 25.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after second injection: MP Joint (n=33) | 5.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after second injection: MP Joint (n=33) | 5.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after second injection: MP Joint (n=32) | 8.5 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for third injection: MP Joint (n=9) | 20.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after third injection: MP Joint (n=9) | 0.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after third injection: MP Joint (n=9) | 10.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after third injection: MP Joint (n=9) | 20.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for follow-up: MP Joint (n=201) | 40.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Follow-up Day 90: MP Joint (n=201) | 0.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Follow-up Day 180: MP Joint (n=207) | 0.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for first injection: PIP Joint (n=98) | 45.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after first injection: PIP Joint (n=98) | 20.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after first injection: PIP Joint (n=97) | 14.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after first injection: PIP Joint (n=98) | 18.5 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for second injection: PIP Joint (n=18) | 40.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after second injection: PIP Joint (n=15) | 30.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after second injection: PIP Joint (n=18) | 30.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after second injection: PIP Joint (n=18) | 27.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for third injection: PIP Joint (n=6) | 37.5 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after third injection: PIP Joint (n=6) | 12.5 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after third injection: PIP Joint (n=6) | 17.5 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after third injection: PIP Joint (n=6) | 20.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for follow-up: PIP Joint (n=93) | 45.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Follow-up Day 90: PIP Joint (n=93) | 20.0 degrees |
| Xiapex | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Follow-up Day 180: PIP Joint (n=93) | 25.0 degrees |
Secondary
Physician Global Assessment of Treatment Satisfaction and Disease Severity
Physician global assessment questionnaire assessed severity of the contracture at baseline, post-injection and TS, improvement from baseline in the treated contracture at post-injection only. Physician's rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Physicians rated participant's improvement in disease severity relative to baseline as very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse.
Time frame: Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection
Population: FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, severity: mild (n=254) | 51 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, severity: moderate (n=254) | 138 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, severity: severe (n=254) | 65 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, severity: normal (n=250) | 60 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, severity: mild (n=250) | 106 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, severity: moderate (n=250) | 62 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, severity: severe (n=250) | 22 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, TS: very satisfied (n=250) | 134 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, TS: satisfied (n=250) | 90 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, TS: neither satisfied/dissatisfied (n=250) | 14 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, TS: dissatisfied (n=250) | 7 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, TS: very dissatisfied (n=250) | 5 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: very much improved (n=250) | 121 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: much improved (n=250) | 88 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: minimally improved (n=250) | 26 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: no change (n=250) | 14 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C1D30, improvement: minimally worse (n=250) | 1 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 2, severity: mild (n=110) | 33 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 2, severity: moderate (n=110) | 53 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 2, severity: severe (n=110) | 24 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, severity: normal (n=108) | 20 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, severity: mild (n=108) | 51 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, severity: moderate (n=108) | 28 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, severity: severe (n=108) | 9 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, TS: very satisfied (n=108) | 63 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, TS: satisfied (n=108) | 36 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, TS: neither satisfied/dissatisfied (n=108) | 5 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, TS: dissatisfied (n=108) | 3 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, TS: very dissatisfied (n=108) | 1 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30,improvement:very much improved (n=108) | 41 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement:much improved (n=108) | 55 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement:minimally improved (n=108) | 8 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C2D30, improvement:no change (n=108) | 4 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 3, severity: mild (n=53) | 16 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 3, severity: moderate (n=53) | 25 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 3, severity: severe (n=53) | 12 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, severity: normal (n=53) | 9 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, severity: mild (n=53) | 24 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, severity: moderate (n=53) | 13 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, severity: severe (n=53) | 7 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, TS: very satisfied (n=53) | 26 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, TS: satisfied (n=53) | 22 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, TS: neither satisfied/dissatisfied (n=53) | 4 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, TS: dissatisfied (n=53) | 1 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: very much improved (n=53) | 22 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: much improved (n=53) | 24 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: minimally improved (n=53) | 5 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C3D30, improvement: no change (n=53) | 2 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 4, severity: mild (n=24) | 10 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 4, severity: moderate (n=24) | 9 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 4, severity: severe (n=24) | 5 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, severity: normal (n=24) | 2 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, severity: mild (n=24) | 11 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, severity: moderate (n=24) | 8 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, severity: severe (n=24) | 3 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, TS: very satisfied (n=24) | 4 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, TS: satisfied (n=24) | 15 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, TS: neither satisfied/dissatisfied (n=24) | 1 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, TS: dissatisfied (n=24) | 1 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: very much improved (n=24) | 6 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: much improved (n=24) | 14 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: minimally improved (n=24) | 3 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C4D30, improvement: no change (n=24) | 1 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 5, severity: mild (n=12) | 5 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 5, severity: moderate (n=12) | 5 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 5, severity: severe (n=12) | 2 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, severity: mild (n= 12) | 7 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, severity: moderate (n= 12) | 3 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, severity: severe (n= 12) | 2 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, TS: very satisfied (n= 12) | 7 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, TS: satisfied (n= 12) | 3 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, TS: neither satisfied/dissatisfied (n= 12) | 2 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, improvement: very much improved (n=12) | 5 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, improvement: much improved (n=12) | 5 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, improvement: minimally improved (n=12) | 1 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | C5D30, improvement: no change (n=12) | 1 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, severity: normal (n=247) | 70 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, severity: mild (n=247) | 117 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, severity: moderate (n=247) | 51 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, severity: severe (n=247) | 9 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, TS: very satisfied (n=247) | 145 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, TS: satisfied (n=247) | 75 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90,TS:neither satisfied/dissatisfied(n=247) | 15 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, TS: dissatisfied (n=247) | 10 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, TS: very dissatisfied (n=247) | 2 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: very much improved (n=247) | 123 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: much improved (n=247) | 95 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: minimally improved (n=247) | 17 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: no change (n=247) | 11 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 90, improvement: much worse (n=247) | 1 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, severity: normal (n=249) | 67 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, severity: mild (n=249) | 114 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, severity: moderate (n=249) | 47 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, severity: severe (n=249) | 21 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, TS: very satisfied (n=249) | 117 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, TS: satisfied (n=249) | 97 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day180,TS:neither satisfied/dissatisfied(n=249) | 15 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, TS: dissatisfied (n=249) | 12 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, TS: very dissatisfied(n=249) | 8 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement:very much improved(n=249) | 94 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: much improved (n=249) | 114 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement:minimally improved(n=249) | 18 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement:no change (n=249) | 13 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: minimally worse (n=249) | 5 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: much worse (n=249) | 4 participants |
| Xiapex | Physician Global Assessment of Treatment Satisfaction and Disease Severity | FU Day 180, improvement: very much worse (n=249) | 1 participants |
Secondary
Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints
Finger goniometry was used to measure the angles of extension and flexion of MP and PIP joints. ROM was measured as the difference between the angle of flexion and the angle of extension of the joint. For each injection, baseline value was the ROM value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the ROM value taken closest and prior to administration of first injection in that joint. ROM was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.
Time frame: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection
Population: FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for first injection: MP Joint (n=208) | 45.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after first injection: MP Joint (n=207) | 65.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after first injection: MP Joint (n=209) | 80.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after first injection: MP Joint (n=209) | 86.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for second injection: MP Joint (n=33) | 60.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after second injection: MP Joint (n=33) | 76.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after second injection: MP Joint (n=32) | 80.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after second injection: MP Joint (n=32) | 80.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for third injection: MP Joint (n=9) | 70.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after third injection: MP Joint (n=9) | 90.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after third injection: MP Joint (n=9) | 80.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after third injection: MP Joint (n=9) | 70.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for follow-up: MP Joint (n=198) | 45.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Follow-up Day 90: MP Joint (n=201) | 90.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Follow-up Day 180: MP Joint (n=207) | 90.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for first injection: PIP Joint (n=98) | 50.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after first injection: PIP Joint (n=98) | 63.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after first injection: PIP Joint (n=97) | 75.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after first injection: PIP Joint (n=98) | 75.5 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for second injection: PIP Joint (n=18) | 50.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after second injection: PIP Joint (n=15) | 50.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after second injection: PIP Joint (n=18) | 67.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after second injection: PIP Joint (n=18) | 65.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for third injection: PIP Joint (n=6) | 57.5 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 1 after third injection: PIP Joint (n=6) | 80.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 7 after third injection: PIP Joint (n=6) | 80.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Day 30 after third injection: PIP Joint (n=6) | 72.5 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for follow-up: PIP Joint (n=93) | 50.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Follow-up Day 90: PIP Joint (n=93) | 72.0 degrees |
| Xiapex | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Follow-up Day 180: PIP Joint (n=93) | 70.0 degrees |
Secondary
Time to Recovery
Time to recovery of normal activities was defined as median number of days between the initial injection date and the date on which participant recovered to normal activities, assessed after first, second and third injection for joints that received 1 through 3 injections. If a participant did not achieve recovery to normal activities, the participant's time to recovery was defined as the median number of days between the initial injection date and the date of the participant's the last daily diary recording within the cycle.
Time frame: Up to Day 30 after first, second and third injection
Population: FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Xiapex | Time to Recovery | Third injection (n=51) | 3.0 days |
| Xiapex | Time to Recovery | First injection (n=230) | 3.0 days |
| Xiapex | Time to Recovery | Second injection (n=103) | 4.0 days |
Other Pre-specified
Number of Participants With Anti-Drug Antibody (ADA)
Human serum ADA samples were analyzed for the presence or absence of anti-clostridial type I collagenase (AUX-I) and anti-clostridial type II collagenase (AUX-II) antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
Time frame: Screening, Follow-up Day 180 after last injection
Population: Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Xiapex | Number of Participants With Anti-Drug Antibody (ADA) | Screening: AUX-I Antibodies (n=248) | 6 participants |
| Xiapex | Number of Participants With Anti-Drug Antibody (ADA) | Screening: AUX-II Antibodies (n=248) | 3 participants |
| Xiapex | Number of Participants With Anti-Drug Antibody (ADA) | Follow-up Day 180: AUX-I Antibodies (n=239) | 220 participants |
| Xiapex | Number of Participants With Anti-Drug Antibody (ADA) | Follow-up Day 180: AUX-II Antibodies (n=239) | 215 participants |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate, radial pulse and body temperature.
Time frame: Screening up to Day 180 after last injection
Population: Safety set included all participants who received at least 1 injection of Xiapex.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xiapex | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 participants |
Other Pre-specified
Number of Participants With Laboratory Abnormalities
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity \[pH\], glucose, protein, blood, ketones, microscopy\[if urine tested positive for blood or protein\]).
Time frame: Screening up to Day 180 after last injection
Population: Safety set included all participants who received at least 1 injection of Xiapex.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xiapex | Number of Participants With Laboratory Abnormalities | 48 participants |